A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation (NHOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by St Luke's Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Council Of Social Service (Singapore)
Information provided by:
St Luke's Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00646347
First received: March 24, 2008
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.


Condition Intervention
Paralytic Stroke
Other: Conventional upper limb stroke rehabilitation
Device: Neuro Hand Orthosis Program (NHOP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by St Luke's Hospital, Singapore:

Primary Outcome Measures:
  • Action Research Arm Test (ARAT) [ Time Frame: week 4 , week 10 , 6 months and 12 months ] [ Designated as safety issue: No ]
  • Motricity Index [ Time Frame: week 4 , week 10 , 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor Activity Log (MAL) [ Time Frame: At admission, week 4 , week 10 , 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Modified Ashworth Scale for grading Spasticity [ Time Frame: At admission, week 4 , week 10 , 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Shoulder pain at admission [ Time Frame: At admission, week 4 , week 10 , 6 months and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Conventional stroke upper limb rehabilitation is given
Other: Conventional upper limb stroke rehabilitation

Patient will be given a ten weeks conventional upper limb therapy. 3 sessions will be provided weekly in the first 4 weeks and 2 therapy sessions will be provided weekly in the subsequent 6 weeks. Patients will receive half an hour of conventional therapy in each session.

Patient will be taught to carry out two and half hours conventional self practice exercise daily for a period of ten weeks.

Active Comparator: B
Neuro Hand Orthosis Program is given
Device: Neuro Hand Orthosis Program (NHOP)

The NHO is based on a design of dynamic hand orthosis for orthopaedic patients after hand surgery. We use it to support CVA patient's wrist and finger to perform grasping to transport an object (ball) from place to place to achieve the follows;

  1. NHO can assist stroke patients to experience successful hand grasping with an object and produce voluntary movement from their paralytic arm. This successful experience will positively reinforce the patient to continue to use their paralytic arm and change the patient's behavior and perception in the arm usage.
  2. The NHO Program is able to engage patients to perform their exercises and activities by themselves independently with the effect of intensive therapy.

The intervention (NHOP) group will receive same treatment intensity as the control group but with a "Neuro Hand Orthosis".


Detailed Description:

The neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. We attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. The patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position.

Since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post stroke between one week to three months and medically stable
  • Right Hemiplegia with right hand dominant
  • Able to stand with minimum assistance
  • AMT score not lesser then 7/10
  • Motricity Index Arm Score <36/100

Exclusion Criteria:

  • Unable to commit to the Neuro Hand Orthosis Program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks
  • Pre-existence shoulder or upper limb pain
  • Pre-existence moderate or severe hand oedema
  • Patients with terminal disease
  • Resident of Institution (eg, Nursing home etc prior to admission)
  • Pre-existing upper limb disability on affected arm
  • Psychiatric problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646347

Contacts
Contact: Gribson Yu Chun Chan, Master 65632281 ext 273 gribsonchan@slh.org.sg

Locations
Singapore
St Luke's Hospital (Singapore) Recruiting
Singapore, 2 Bukit Batok, Street11, Singapore, 659674
Contact: Gribson Chan Yu Chun, Master    689532281 ext 237    gribsonchan@slh.org.sg   
Principal Investigator: Gribson Chan Yu Chun, Master         
Sponsors and Collaborators
St Luke's Hospital, Singapore
National Council Of Social Service (Singapore)
Investigators
Principal Investigator: Gribson Yu Chun Chan, Master St Luke's Hospital, Singapore
  More Information

No publications provided

Responsible Party: Gribson Chan Yu Chun Senior Rehabilitation Manager, St Luke's Hosptial
ClinicalTrials.gov Identifier: NCT00646347     History of Changes
Other Study ID Numbers: slhdoc02
Study First Received: March 24, 2008
Last Updated: February 4, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by St Luke's Hospital, Singapore:
stroke
upper limb rehabilitation
treatment
movement recovery from sever paralytic upper limb
neuro hand orthosis
self practice program
subacute

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014